국가임상시험지원재단

페이스북 유튜브

Related Sites

Related Sites

Government Agency
Ministry of Health and Welfare
Ministry of Food and Drug Safety
Korea Disease Control and Prevention Agency
National Health Insurance Service
Korea Health Industry Development Institute
Health Insurance Review & Assessment Service
Korea Drug Development Fund
National Institute of Health
National Cancer Center
National Institute of Food and Drug Safety Evaluation
Korea Health Information Service
Clinical Trial Center
CHA UNIVERSITY BUNDANG MEDICAL CENTER
Gachon University Gil Medical Center
THE CATHOLIC UNIVERSITY OF KOREA SEOUL ST.MARY'S HOSPITAL
GANGNAM SEVERANCE HOSPITAL
KYUNG HEE UNIVERSITY HOSPITAL AT GANGDONG
KONKUK UNIVERSITY MEDICAL CENTER
KYUNGPOOK NATIONAL UNIVERSITY HOSPITAL
KOREA UNIVERSITY GURO HOSPITAL
KOREA UNIVERSITY ANAM HOSPITAL
DONGGUK UNIVERSITY MEDICAL CENTER
DONG-A UNIVERSITY HOSPITAL
BESTIAN SEOUL HOSPITAL
PUSAN NATIONAL UNIVERSITY HOSPITAL
SEOUL NATIONAL UNIVERSITY BUNDANG HOSPITAL
SAMSUNG MEDICAL CENTER
SEOUL NATIONAL UNIVERSITY HOSPITAL
ASAN MEDICAL CENTER
SEVERANCE HOSPITAL
Ajou University Hospital
YANGJI HOSPITAL
WONKWANG UNIVERSITY HOSPITAL
EWHA WOMANS UNIVERSITY MOKDONG HOSPITAL
INJE UNIVERSITY BUSAN PAIK HOSPITAL
INHA UNIVERSITY HOSPITAL
CHONNAM NATIONAL UNIVERSITY HOSPITAL
JEONBUK NATIONAL UNIVERSITY HOSPITAL
CHUNGNAM NATIONAL UNIVERSITY HOSPITAL
CHUNGBUK National University Hospital
ULSAN UNIVERSITY HOSPITAL
HALLYM UNIVERSITY SACRED HEART HOSPITAL
HANYANG UNIVERSITY MEDICAL CENTER
CRO
kolab Health Sciences
PROMEDIS
GSK
D2S
Medical Writing
Synex
SEOUL CRO
SYMYOO
CC&I RESEARCH
C&R RESEARCH
ADM KOREA Inc.
AllLiveC
JNPMEDI
MEDI HELP LINE
BDM Consulting, Inc
LSK Global PS
Caleb Multilab Inc.
IQVIA
CLIPS BnC
PharmaCRO
Analytical CRO/Central LAB
Internationla Scientific Standards
PROMEDIS
GCCL
SML Meditree
Caleb Multilab Inc.
Organization
Korean Research-based Pharma Industry Association
Korea Biomedicine Industry Association
KOREA BIO
Korea Drug Research Association
Korea Pharmaceutical and Bio-Pharma Manufacturers Association
Society/School
Korean Association for the Study of the Liver
The Korean Society of Infectious Diseases
Korean Cancer Association
Korean Academy of Medical Sciences
Korean Cancer Study Group
Innovative Center of Bio-imaging Guided Drug Discovery and Development
The Korean Society of Pharmaceutical Medicine
Information Service
Clinical Research Information Service(Korea Disease Control and Prevention Agency)
PHARMA KOREA(Korea Health Industry Development Institute)
Related Agency
Governmet Regulatory Agency
(USA) FDA(U.S. Food & Drug Administration)
(China) NMPA(National Medical Products Administration)
(Europe) EMA(European Medicines Agency)
(UK) MHRA(Medicines & Healthcare products Regulatory Agency)
(Canada) Health Canada
(Australia) TGA(Therapeutic Goods Administration)
(India) CDSCO(Central Drugs Standard Control Organization)
(Japan) MHLW(Ministry of Health, Labour, and Welfare)
(Japan) PMDA(Pharmaceuticals & Medical Devices Agency)
(Singapore) HSA(Health Sciences Authority)
(Taiwan) TFDA(Taiwan Food and Drug Administration)
(Hong Kong) DO(Drug Office)
(Thailand) FDA Thailand
(Vietnam) DAV(Drug Administration of Vietnam)
(Indonesia) NA-DFC(Indonesia National Agency of Drug and Food Control)
Support Agency
(USA) ACRES(Alliance for Clinical Research Excellence and Safety)
(USA) AARHPP(Association for the Accreditation of Human Research Protection Program)
(USA) ACRP(Association of Clinical Research Professionals)
(USA) CenterWatch
(USA) DIA(Drug Information Association)
(USA) NIH(National Institutes of Health)
(USA) NCI(National Cancer Institute)
(USA) MIT CRITICAL DATA
(USA) TransCelerate
(Europe) ECRIN(European Clinical Research Infrastructure Network)
(UK) UKCRC(UK Clinical Research Collaboration)
(UK) NIHR(National Institute for Health Research)
(Australia) Australian Clinical Trials
(Japan) TRI(Translational Research Informatics Center)
(Japan) AMED(Japan Agency for Medical Research and Development)
(Singapore) SCRI(Singapore Clinical Research Institute)
(Netherlands) IFAPP(International Federation of Associations of Pharmaceutical Physicians)
(Saudi Arabia) KAIMRC(King Abdullah International Medical Research Center)

Government Agency

Ministry of Health and Welfare
Ministry of Food and Drug Safety
Korea Disease Control and Prevention Agency
National Health Insurance Service
Korea Health Industry Development Institute
Health Insurance Review & Assessment Service
Korea Drug Development Fund
National Institute of Health
National Cancer Center
National Institute of Food and Drug Safety Evaluation
Korea Health Information Service

Clinical Trial Center

CHA UNIVERSITY BUNDANG MEDICAL CENTER
Gachon University Gil Medical Center
THE CATHOLIC UNIVERSITY OF KOREA SEOUL ST.MARY'S HOSPITAL
GANGNAM SEVERANCE HOSPITAL
KYUNG HEE UNIVERSITY HOSPITAL AT GANGDONG
KONKUK UNIVERSITY MEDICAL CENTER
KYUNGPOOK NATIONAL UNIVERSITY HOSPITAL
KOREA UNIVERSITY GURO HOSPITAL
KOREA UNIVERSITY ANAM HOSPITAL
DONGGUK UNIVERSITY MEDICAL CENTER
DONG-A UNIVERSITY HOSPITAL
BESTIAN SEOUL HOSPITAL
PUSAN NATIONAL UNIVERSITY HOSPITAL
SEOUL NATIONAL UNIVERSITY BUNDANG HOSPITAL
SAMSUNG MEDICAL CENTER
SEOUL NATIONAL UNIVERSITY HOSPITAL
ASAN MEDICAL CENTER
SEVERANCE HOSPITAL
Ajou University Hospital
YANGJI HOSPITAL
WONKWANG UNIVERSITY HOSPITAL
EWHA WOMANS UNIVERSITY MOKDONG HOSPITAL
INJE UNIVERSITY BUSAN PAIK HOSPITAL
INHA UNIVERSITY HOSPITAL
CHONNAM NATIONAL UNIVERSITY HOSPITAL
JEONBUK NATIONAL UNIVERSITY HOSPITAL
CHUNGNAM NATIONAL UNIVERSITY HOSPITAL
CHUNGBUK National University Hospital
ULSAN UNIVERSITY HOSPITAL
HALLYM UNIVERSITY SACRED HEART HOSPITAL
HANYANG UNIVERSITY MEDICAL CENTER

CRO

kolab Health Sciences
PROMEDIS
GSK
D2S
Medical Writing
Synex
SEOUL CRO
SYMYOO
CC&I RESEARCH
C&R RESEARCH
ADM KOREA Inc.
AllLiveC
JNPMEDI
MEDI HELP LINE
BDM Consulting, Inc
LSK Global PS
Caleb Multilab Inc.
IQVIA
CLIPS BnC
PharmaCRO

Analytical CRO/Central LAB

Internationla Scientific Standards
PROMEDIS
GCCL
SML Meditree
Caleb Multilab Inc.

Organization

Korean Research-based Pharma Industry Association
Korea Biomedicine Industry Association
KOREA BIO
Korea Drug Research Association
Korea Pharmaceutical and Bio-Pharma Manufacturers Association

Society/School

Korean Association for the Study of the Liver
The Korean Society of Infectious Diseases
Korean Cancer Association
Korean Academy of Medical Sciences
Korean Cancer Study Group
Innovative Center of Bio-imaging Guided Drug Discovery and Development
The Korean Society of Pharmaceutical Medicine

Information Service

Clinical Research Information Service(Korea Disease Control and Prevention Agency)
PHARMA KOREA(Korea Health Industry Development Institute)

Related Agency

(USA) FDA(U.S. Food & Drug Administration)
(China) NMPA(National Medical Products Administration)
(Europe) EMA(European Medicines Agency)
(UK) MHRA(Medicines & Healthcare products Regulatory Agency)
(Canada) Health Canada
(Australia) TGA(Therapeutic Goods Administration)
(India) CDSCO(Central Drugs Standard Control Organization)
(Japan) MHLW(Ministry of Health, Labour, and Welfare)
(Japan) PMDA(Pharmaceuticals & Medical Devices Agency)
(Singapore) HSA(Health Sciences Authority)
(Taiwan) TFDA(Taiwan Food and Drug Administration)
(Hong Kong) DO(Drug Office)
(Thailand) FDA Thailand
(Vietnam) DAV(Drug Administration of Vietnam)
(Indonesia) NA-DFC(Indonesia National Agency of Drug and Food Control)
Support Agency
(USA) ACRES(Alliance for Clinical Research Excellence and Safety)
(USA) AARHPP(Association for the Accreditation of Human Research Protection Program)
(USA) ACRP(Association of Clinical Research Professionals)
(USA) CenterWatch
(USA) DIA(Drug Information Association)
(USA) NIH(National Institutes of Health)
(USA) NCI(National Cancer Institute)
(USA) MIT CRITICAL DATA
(USA) TransCelerate
(Europe) ECRIN(European Clinical Research Infrastructure Network)
(UK) UKCRC(UK Clinical Research Collaboration)
(UK) NIHR(National Institute for Health Research)
(Australia) Australian Clinical Trials
(Japan) TRI(Translational Research Informatics Center)
(Japan) AMED(Japan Agency for Medical Research and Development)
(Singapore) SCRI(Singapore Clinical Research Institute)
(Netherlands) IFAPP(International Federation of Associations of Pharmaceutical Physicians)
(Saudi Arabia) KAIMRC(King Abdullah International Medical Research Center)

* Criteria for posting CROs: CRO Autonomous Registration Agency

Why Korea Why Korea

Why Choose Korea
for Clinical Trials?
  • The Korean government has undertaken significant steps to streamline the regulatory process, and is committed to continuous harmonization with global standards. Important regulatory reforms include the implementation of GCP guidelines (from 1995), the introduction and separation of IND from the NDA review process (in 2002), a reduction of the IND approval timeline to 30 working days, and support for participation in multi-regional clinical trials.

These regulatory reform efforts are ongoing and Ministry of Food and Drug Safety(MFDS) announced the '5-yearcomprehensive plans for clinical trial development' in2019 to become the patient-centered new drug developing powerhouse. The plans include facilitating preliminary IND review system to foster early phase studies. Once safety data confirmed through this pre-review meeting, approval timeline may be shortened(30days->7days) The IRB approval process typically occurs in parallel to an MFDS review, with busy sites holding IRB meetings on a weekly basis.

Korea’s public healthcare system also ensures reimbursement for most medical expenses, such that an estimated 97% of the 51 million population benefits from healthcare coverage via the national insurance system.

Major university hospitals are generally larger than 1,000 beds and receive as many as 10,000 or more outpatients a day. Designated clinical trial centers (CTCs) affiliated with these hospitals have access to a large and diverse patient pool and benefit from rapid patient recruitment. Accordingly, Korean CTCs are widely recognized as among the fastest patient recruitment sites in the world, and boast relatively low drop-out rates during the conduct of clinical trials.

Korea’s CTCs are home to world-class facilities and infrastructure, while an outstanding oversight of quality control, staff management and development ensures the successful conduct of patient as well as healthy volunteer clinical trials.

Furthermore, there are over 170 clinical trial sites inspected and certified by the Korea Ministry of Food and Drug Safety (MFDS, formerly KFDA). According to the US FDA, which has conducted due diligence in Korea since 2008, Korea maintains a perfect record with no major official actions recorded for any clinical or non-clinical trials.

Last but not least, Korean investigators regularly receive intensive GCP training in these major hospitals nationwide.